Key Innovation
A computational leap turned a pocket-sized device into hospital-grade diagnostics.
Cable-Free Synthesized ECG
Client
HeartBeam
Practice Areas
Core Disciplines
Overview
HeartBeam collaborated with Triple Ring to develop an innovative telehealth solution designed to transform the detection and monitoring of cardiac conditions. The goal was to create a compact, portable cardiac monitoring device capable of collecting ECG signals in three dimensions and synthesizing them into a clinically meaningful 12-lead ECG.
The resulting platform supports remote cardiac monitoring by enabling physicians to access real-time data outside traditional clinical settings, expanding access to cardiac diagnostics and improving patient care workflows.
Challenge
HeartBeam sought to develop a personal, cable-free, and easy-to-use cardiac monitoring solution for both in-clinic and at-home use. The objective was to create a credit card-sized ECG recording device that leverages vectorcardiography (VECG) and integrates with cloud-based software to deliver critical patient data to physicians in real time.
Achieving this required coordinating multidisciplinary device development while meeting regulatory requirements and supporting rapid product development timelines.
Solution
HeartBeam partnered with Triple Ring to execute a comprehensive, five-phase expedited device development program spanning early R&D, industrial design, product development, manufacturing readiness, and regulatory preparation.
Triple Ring applied expertise in wearable medical device design and system integration to develop the cable-free ECG device and supporting ecosystem. The program included device builds for design verification and validation, packaging development, and manufacturing technology transfer to support scalable production.
Key development activities included:
- Designing compact wearable hardware capable of capturing three-dimensional ECG signals
- Integrating smartphone-based communication to transmit data securely
- Developing cloud-connected workflows that enabled remote physician access
- Supporting regulatory preparation for FDA 510(k) submission and validation
Cable-Free Synthesized ECG
Overview
HeartBeam collaborated with Triple Ring to develop an innovative telehealth solution designed to transform the detection and monitoring of cardiac conditions. The goal was to create a compact, portable cardiac monitoring device capable of collecting ECG signals in three dimensions and synthesizing them into a clinically meaningful 12-lead ECG.
The resulting platform supports remote cardiac monitoring by enabling physicians to access real-time data outside traditional clinical settings, expanding access to cardiac diagnostics and improving patient care workflows.
Challenge
HeartBeam sought to develop a personal, cable-free, and easy-to-use cardiac monitoring solution for both in-clinic and at-home use. The objective was to create a credit card-sized ECG recording device that leverages vectorcardiography (VECG) and integrates with cloud-based software to deliver critical patient data to physicians in real time.
Achieving this required coordinating multidisciplinary device development while meeting regulatory requirements and supporting rapid product development timelines.
Solution
HeartBeam partnered with Triple Ring to execute a comprehensive, five-phase expedited device development program spanning early R&D, industrial design, product development, manufacturing readiness, and regulatory preparation.
Triple Ring applied expertise in wearable medical device design and system integration to develop the cable-free ECG device and supporting ecosystem. The program included device builds for design verification and validation, packaging development, and manufacturing technology transfer to support scalable production.
Key development activities included:
- Designing compact wearable hardware capable of capturing three-dimensional ECG signals
- Integrating smartphone-based communication to transmit data securely
- Developing cloud-connected workflows that enabled remote physician access
- Supporting regulatory preparation for FDA 510(k) submission and validation
Client
HeartBeam
Practice Areas
Core Disciplines
Outcome
The HeartBeam–Triple Ring collaboration produced a personal, cable-free synthesized 12-lead ECG solution that enables patients to record cardiac data at home. The device integrates with a smartphone application that communicates with the HeartBeam Cloud, where synthesized ECG data is compared with baseline records and made available to physicians remotely.
This multidisciplinary and fast-paced program resulted in a successful 510(k) submission to the U.S. Food and Drug Administration (FDA) and regulatory clearance in 2024 for the hardware that leverages vectorcardiography and collects 3D ECG data. The synthesized 12-lead ECG algorithm remains pending FDA clearance.
The completed system enables physicians to remotely monitor cardiac conditions and guide patient care outside traditional healthcare facilities, supporting new models of telehealth-enabled cardiac diagnostics.
Triple Ring Talent
The Story Behind the Innovation
At Triple Ring, we draw on a deep bench of expertise across diverse disciplines matched to each innovation challenge. For this project, our team applied expertise in wearable medical device design, system integration, and regulatory strategy to deliver a cable-free, credit card-sized ECG device — from early R&D through successful FDA 510(k) clearance in 2024.
Walt and Kevin collaborated with many talented colleagues across Triple Ring and HeartBeam on this project.
Walt Cecka
Medical Device Design & Translational Medicine
Walt Cecka brings decades of experience translating novel medical technologies into first-to-market products. He works closely with innovators to shape early concepts into structured development programs that advance patient care across a wide range of clinical applications.
Kevin Dunk
Mechanical & Aerospace Engineering
Kevin Dunk brings expertise in mechanical engineering and multidisciplinary product development across the full device lifecycle. His work supports teams from early prototypes through verification and manufacturing, helping ensure systems are reliable, scalable, and ready for real-world use.
